Job Description
Cure Talent are delighted to be partnered with an exciting Diagnostics company, specialising in GI Cancer, who, due to their continued growth, have an exciting opportunity for a QARA Specialist to join them.
As the new QARA Specialist, you will work closely with the QA & RA Managers to develop and manage the existing QMS and work closely on the implementation and transition to an eQMS. Alongside this you will be heavily involved in CAPA & NCR processes, SOP creation, auditing and RA support.
We are looking for an experienced Quality Assurance professional with a proven background in In Vitro Diagnostics or Medical Devices. You will have strong experience in the management and/or implementation of an ISO 13485 QMS, CAPA processes and auditing.
Key Responsibilities:
- Develop and Maintain ISO 13485 QMS
- Support the implementation and transition to an eQMS
- Creation and implementation of SOPs
- CAPA Process
- Auditing
- Support RA with Risk Management, Clinical Study Documents and Technical Files
Qualifications:
- Degree educated in a relevant scientific or technical field
- Proven experience in the IVD or Medical Device Industries
- Proven experience in the maintenance and/or implementation of an ISO 13485 QMS
- Proven experience and knowledge of CAPA Process and Auditing
- Auditing certification is highly advantageous
If you have the necessary skills and experience to be successful in this role, please get in touch with the team at Cure Talent today!